Cl II Orthoscan Mobile Mini C-arm system

Company:OrthoScan Inc
Date of Enforcement Report 1/17/2018
Class lI:

PRODUCT

Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures..
Recall Number Z-0258-2018 to Z-0261-2018

REASON
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user.

RECALLING FIRM/MANUFACTURER
OrthoScan Inc., Scottsdale, AZ on 8/31/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2012 total

DISTRIBUTION
Nationwide and Internationally

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Software Verification

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.